“… the people you’ve been talking with are just not seeing all the components of the global biopharmaceutical industry — and this huge market opportunity. China will become a big player in biologics. This is only natural; there’s good reason for that.” Here’s a more positive outlook on the current situation in China, from Eric Langer, President, BioPlan Associates, Inc.
A sense of accomplishment from problem-solving and discovery is why many of us do what we do in drug product development. However, formulations scientists, analytical chemists, and procurement specialists do not choose their projects.
Part 3 of Identifying And Resolving Errors, Defects, And Problems Within Your Organization — a five-part series on operationalizing proper improvement techniques.
With the recent breakthroughs in cell and gene therapy, there is increased emphasis on the design and implementation of different supply chain models to support the movement of materials and drug product across the chain of care. Unlike more traditional supply chains, many of these therapies have unpredictable sources and manufacturing and infusion locations. The most extreme example is loosely referred to as the “vein-to-vein” supply chain — particularly for autologous therapies.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices – choices that can be conflicting or present differing advantages.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
When asked about the biggest challenges to the pharmaceutical company sponsor-contract service provider relationship, sponsors and service providers offer pretty consistent responses.
Many leading life sciences companies have introduced cost-reduction initiatives to automate routine, non-value-added tasks related to data capture, cataloguing and documentation activities as products move from discovery through development to late-stage quality control, manufacturing and commercial operations.
Partnering with a specialist CRO is an ideal way to quickly and cost-effectively manage development. Biopharmaceutical manufacturing is increasingly focused on productivity and efficiency. A changing economic climate, together with the patent cliff of many major products, has resulted in drastic changes in the business models of a whole industry. It’s no longer simply the repetitive, simple tasks, that are outsourced, but increasingly complex specialized tasks including research and development, when pursuing the identification of new chemical and biochemical entities. By Dr. Laura Ciccolini
Anyone in business in the current economic climate knows that life is a constant struggle. Financial constraints, limitations on capital budget spend, and the ever-increasing need to reduce costs are all adding to the burden of trying to stay in business – and stay competitive. Inevitably, we all share some common challenges. By Patrick Jackson, Vindon Scientific
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
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Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Determine your plan now for serialization readiness to put the worries of DSCSA costs and timelines behind you and patient safety back where it belongs — at the forefront.
With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.
As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help.
To allay fears about continuous manufacturing changes, utilize the valuable tools and resources that the FDA has created. Seeking the agency's insight early will also give you a clearer path for success.
To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.
